Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury

Launched by METROHEALTH MEDICAL CENTER · Nov 15, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment option for people with spinal cord injuries (SCI) who experience fecal incontinence, which is the inability to control bowel movements. The study will test a technique called genital nerve stimulation (GNS) using non-invasive electrodes to see if it can help improve bowel function and reduce accidents. By measuring how the anus and rectum respond to this stimulation, researchers hope to understand if GNS can make a positive difference for those living with SCI.

To participate in the study, individuals must be at least 18 years old and have experienced a traumatic spinal cord injury for at least six months. They should also have a neurological injury at T12 level or higher and show a response to the genital nerve stimulation during screening. Participants will be asked to undergo several tests to monitor bowel function, and the study will collect information about their health and daily life. This research aims to provide more options for managing bowel issues, which can significantly affect quality of life for people with spinal cord injuries.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Traumatic SCI
• • Minimum 6 months post-injury
• • Aged 18 years or older
• • Neurological level of injury T12 or higher AIS grade A-D defined by ISNCSCI
• • Response to genital nerve stimulation upon screening
• • Able to understand and provide informed consent
• Exclusion Criteria:
• • Currently enrolled in another functional electrical stimulation (FES) research trial
• • Females who are pregnant or planning to become pregnant during the trial
• • Presence of cardiac pacemaker, implanted defibrillator or other implanted FES device if, upon clinical exam, it may have an interaction with GNS.
• • In the judgement of the PI or Co-Investigators, presence of medical complications that may interfere with the execution of the study.